Method of gait evaluation and training with differential pressure system

ABSTRACT

There is described an integrated unweighted gait training system having an unweighting system comprising a computer controller; a gait measurement system in communication with the controller; and a display in communication with the computer controller adapted and configured to provide real-time feedback to a user of the integrated unweighting gait training system. The unweighting system may be a differential air pressure (DAP) unweighting system or a non-DAP unweighting system.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/769,111, filed Aug. 20, 2015, titled “METHOD OF GAIT EVALUATION ANDTRAINING WITH DIFFERENTIAL PRESSURE SYSTEM,” now U.S. Pat. No.10,342,461, which is a national phase application under 35 USC 371 ofInternational Patent Application No. PCT/US2014/029578, filed Mar. 14,2014, titled “METHOD OF GAIT EVALUATION AND TRAINING WITH DIFFERENTIALPRESSURE SYSTEM,” now International Publication No. WO 2014/153201,which claims priority to U.S. Provisional Patent Application No.61/785,317, filed Mar. 14, 2013, titled “METHOD OF GAIT EVALUATION ANDTRAINING WITH DIFFERENTIAL PRESSURE SYSTEM,” each of which is hereinincorporated by reference in its entirety.

This application may be related to any of the following patentapplications, each of which is herein incorporated by reference in itsentirety: U.S. Provisional Patent Application No. 61/651,415, filed onMay 24, 2012, U.S. Pat. No. 7,591,795 issued on Sep. 22, 2009, U.S.application Ser. No. 12/236,459 filed on Sep. 23, 2008, U.S. applicationSer. No. 12/236,465 filed on Sep. 23, 2008, U.S. application Ser. No.12/236,468 filed on Sep. 23, 2008, International Application No.PCT/US2006/038591 filed on Sep. 28, 2006, U.S. Provisional ApplicationNo. 60/999,102 filed on Oct. 15, 2007, U.S. Provisional Application No.60/999,101 filed on Oct. 15, 2007, U.S. Provisional Application No.60/999,061 filed on Oct. 15, 2007, U.S. Provisional Application No.60/999,060 filed on Oct. 15, 2007, U.S. application Ser. No. 12/761,316filed on Apr. 15, 2010, U.S. application Ser. No. 12/761,312 filed onApr. 15, 2010, International Application No. PCT/US2008/011832 filed onOct. 15, 2008, International Application No. PCT/US2008/011807 filed onOct. 15, 2008, U.S. Provisional Application No. 61/178,901 filed on May15, 2009, U.S. application Ser. No. 12/778,747 filed on May 12, 2010,International Application No. PCT/US2010/034518 filed on May 12, 2010,U.S. Design application Ser. No. 29/337,097 filed on May 14, 2009, U.S.Provisional Application No. 61/454,432 filed on May 18, 2011, U.S.application Ser. No. 13/423,124 filed on Mar. 16, 2012, InternationalApplication No. PCT/US2012/029554 filed on Mar. 16, 2012 and U.S. Pat.No. 5,133,339 issued on Jul. 28, 1992.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

This application relates to biomechanical evaluation and trainingsystems, especially those for correction or improvement of gait andespecially in conjunction with an assistance system such as adifferential air pressure assistance system.

BACKGROUND

Gait correction is a key goal of therapists in healing and trainingtheir patients. Gait training helps injured patients to recover frominjuries that affect how they run, walk, and jog and helps preventfuture injuries. Even though methods of quantitative measuring gait arewell known, there are significant limitations in current methods. Manygait evaluation tools are designed primarily to measure gait function atfull body weight, and many patients are unable to bear full body weightor have abnormal gait at full body weight and lack the ability toeffectively alter their gait under such load. Additionally, thesesystems are typically designed for investigational purposes, presentingdetailed data to analysis-oriented researchers. Unloading systems suchas harnesses or pools apply pressure in a fashion that alters gaitundesirably and therefore impair accurate evaluation or training ofgait. Due to the way differential air pressure unweighing systemssupport their patients, they do not introduce the same external factorsthat harnesses and pools do. Because of the lack of gait measurementtools in differential air pressure systems, many clinical therapists,who are tasked with correcting gait and not only measuring it, oftenrely exclusively on their experience to estimate what and how thepatient should be training with respect to their gait. This approach hasshown to be effective, however the practice is more art than science, sostandard of care can vary between therapists providing treatment.

Though a number of gait measurement tools exist primarily for laboratoryenvironments, there are several reasons why these systems are not widelyused in the rehab environment. In the lab environment, the tools toinstrument a patient are generally more costly than most therapy centerscan afford. The laboratories themselves are designed to gather data, notto effectively treat patient problems. Even an analysis done on the datathat has been gathered is rarely helpful to the patient during thetreatment session, partially because the labs do not have quantitativedata available in real time. Often the data is also not presented in anunderstandable way so laboratory environments are sub-optimal attreating patients.

In addition to the limitations of the current equipment used for gaitmeasurement, many patients simply lack the strength or experience toomuch pain to perform suitably in full weightbearing systems to attaingait improvements. As a result of the variations in patient trainingability as well as the variety of gait systems, there remains a need forimproved systems to train and improve gait in patients.

SUMMARY OF THE DISCLOSURE

In general, in one embodiment, an integrated unweighted gait trainingsystem, includes an unweighting system comprising a computer controller,a gait measurement system in communication with the controller, and adisplay in communication with the computer controller adapted andconfigured to provide real-time feedback to a user of the integratedunweighting gait training system.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the unweighting system can be a differentialair pressure unweighting system. In another aspect, the unweightingsystem can be a non-DAP unweighting system. In a further aspect, thenon-DAP unweighting system can be a support frame type non-DAPunweighting system. In an alternative aspect, the non-DAP unweightingsystem can be a curved arch type non-DAP unweighting system. In yetanother aspect, the non-DAP unweighting system can be an unweightingarch type non-DAP unweighting system. In still another aspect, thenon-DAP unweighting system can be a monocolumn type non-DAP unweighingsystem. In one aspect, the non-DAP unweighting system can be acantilevered type non-DAP unweighting system. In another aspect, thegait measurement system can further include an enclosure, a pair ofsensors supported by the enclosure and positioned such that when theenclosure is coupled to a treadmill of the integrated unweighting systema portion of the tread is within the detectable range of the pair ofsensors, and a processor in communication with the pair of sensors andhaving computer readable instructions to receive and process an outputfrom the pair of sensors and to perform calculations related toobtaining gait parameters based on the input from the sensors. In afurther aspect, the processor can perform calculations to obtain treadbelt speed, time of foot impact and left/right foot indication.

In general, in one embodiment, a self-contained gait feedback device fordetecting motion of a user on a treadmill includes an enclosure, a pairof sensors supported by the enclosure and positioned such that when thehousing is coupled to the treadmill a portion of the tread is within thedetectable range of the pair of sensors, a processor supported by theenclosure and in communication with the pair of sensors and havingcomputer readable instructions to receive and process an output from thepair of sensors, and a display in communication with the processorsupported by the disclosure.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the self-contained feedback device can includethe computer readable instructions to receive and process an output fromthe sensors and can further include performing calculations related toobtaining one of more gait parameters based in part on the output fromthe pair of sensors. In another aspect, the self-contained feedbackdevice can include the computer readable instructions to receive andprocess an output from the sensors and can further include outputtingthe one of more gait parameters to the display. In a further aspect, theself-contained feedback device can include the display and can furtherinclude a processor having computer readable instructions for receivingand performing calculations related to obtaining one of more gaitparameters based in part on the output from the pair of sensors. In analternative aspect, the self-contained feedback device can include thecomputer readable instructions of the processor in the display and canfurther include outputting the one of more gait parameters on thedisplay. In yet another aspect, the processor can be adapted andconfigured to provide clock signal synchronized sensor output data fromthe pair of sensors. In still another aspect, the processor can beadapted and configured to provide clock signal synchronized sensoroutput data from the pair of sensors. In one aspect, the sensors can beIR sensors, optical mouse sensors, laser sensors, proximity sensors, orlight sensors. In another aspect, the display can be a PC, a tablet or asmart phone. In a further aspect, communication with the display can bewired or wirelessly. In an alternative aspect, the display can be incommunication with the processor supported by the enclosure. In yetanother aspect, the self-contained feedback device can further includean unweighting system positioned to provide controlled unweighting of auser of the treadmill, the unweighting system can have a computercontroller in communication with the processor. In still another aspect,the display can be adapted and configured to provide real-time feedbackto a user of the unweighting system. In one aspect, the unweightingsystem can be a differential air pressure unweighting system. In anotheraspect, the unweighting system can be a non-DAP unweighting system. In afurther aspect, the non-DAP unweighting system can be a support frametype non-DAP unweighting system. In an alternative aspect, the non-DAPunweighting system can be a curved arch type non-DAP unweighting system.In yet another aspect, the non-DAP unweighting system can be anunweighting arch type non-DAP unweighting system. In still anotheraspect, the non-DAP unweighting system can be a monocolumn type non-DAPunweighing system. In still another aspect, the non-DAP unweightingsystem can be a cantilevered type non-DAP unweighting system.

In general, in one embodiment, an integrated differential air pressureassisted gait training system includes a differential air pressuresystem having a computer controller, at least one gait measurement orindication system in communication with the computer controller, and acomputer readable database stored within or accessible to the computercontroller comprising collected DAP system data from the differentialair pressure system and gait system data from the at least one gaitmeasurement or indication system

This and other embodiments can include one or more of the followingfeatures. In one aspect, the DAP system data can include one or more ofpressure setting and control, calibration data, system type, auxiliarysystems, exercise system controls. In another aspect, the gait systemdata can include video, user worn sensor or equipment sensor. In afurther aspect, the computer readable database can further includesynthesized data from at least one of DAP system data or gait systemdata. In an alternative aspect, the synthesized data can be triggeredfrom another data stream. In still another aspect, the synthesized datacan be processed data by manipulating one or more data streams. In oneaspect, the synthesized data can be calculated data by comparing orrelating two or more data streams. In another aspect, the synthesizeddata can include using algorithms to produce outcomes of one or moredata streams. In a further aspect, can further include a display incommunication with the computer controller adapted and can be configuredto provide real-time feedback to a user of the differential air pressuresystem. In an alternative aspect, the system can further include videoinput in database. In yet another aspect, the video data stored can becollected based on a trigger from another component or device of theintegrated system. In still another aspect, the database can beaccessible to computer controller or accessible to the controller viawired or wireless communication. In one aspect, the system can includeat least one gait measurement or indication system and can furtherinclude an enclosure, a pair of sensors supported by the enclosure andpositioned such that when the enclosure is coupled to a treadmill of theintegrated unweighting system a portion of the tread can be within thedetectable range of the pair of sensors, and a processor supported bythe enclosure and in communication with the pair of sensors and havingcomputer readable instructions to receive and process an output from thepair of sensors and to perform calculations related to obtaining gaitparameters based on the input from the sensors.

In general, in one embodiment, a method of training an individual toimprove or alter walking or running mechanics by unweighting includespreparing the individual for training in a differential air pressureenvironment provided by a differential air pressure system, performing atraining routine with the individual to improve or alter walking orrunning mechanics while the user is experiencing unweighting by thedifferential air pressure system, simultaneously measuring one or moreof a user gait parameter or a user biomechanical parameter during theperforming step, and collecting the one or more measured user gaitparameter or measured user biomechanical parameter under instructionsfrom a controller of the differential air pressure system.

In general, in one embodiment, a method of training an individual toimprove or alter walking or running mechanics by unweighting includespreparing the individual for training in a non-differential air pressureenvironment provided by a non-differential air pressure system,performing a training routine with the individual to improve or alterwalking or running mechanics while the user is experiencing unweightingby the non-differential air pressure system, simultaneously measuringone or more of a user gait parameter or a user biomechanical parameterduring the performing step, and collecting the one or more measured usergait parameter or measured user biomechanical parameter underinstructions from a controller of the non-differential air pressuresystem.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the preparing step can further include the useraccessing the differential air pressure environment and initiating thetraining without assistance. In another aspect, the preparing step canfurther include the user accessing the differential air pressureenvironment without assistance and initiating or performing the trainingwith assistance. In a further aspect, the assistance during performingthe training can be provided by a person. In an alternative aspect, theassistance during performing the training can be provided automaticallyby the differential air pressure system. In yet another aspect, thecollecting step can further include collecting the individual's heartrate and a treadmill incline measurement. In still another aspect, thecollecting step can further include collecting a signal from a heartrate monitor worn by the individual. In one aspect, the collecting stepcan further include collecting data from a gyroscopic sensor or anaccelerometer sensor worn by the patient. In another aspect, the one ormore parameters of the user's gait or biomechanics can be one or moreof: a stride length, a ground reaction force, a lateral movement of aknee, an angle of a knee, an angle of an ankle, a strike pattern of aforefoot, a strike pattern of a heel, a muscle activation pattern, and amovement symmetry.

In general, in one embodiment, a method of providing integrateddifferential air pressure assisted gait training includes unweightingthe user in an integrated differential air pressure system, performing atherapy routine with the user, collecting under control of theintegrated differential air pressure system controller output data froma plurality of components of the integrated differential air pressuresystem during the unweighting step and the performing step, andrecommending a user action for gait correction based on one or more ofthe output data from the collecting step.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the output data can include synthesized data.In another aspect, the collecting step can further include a continuousoutput data stream, a nearly continuous output data stream, a segmentedoutput data stream, or a synthesized output data stream from theintegrated differential air pressure system. In a further aspect, themethod can further include storing the output data in a database. In analternative aspect, the database can contain DAP and gait system datacorresponding to a user's progress through a continuum of care. In yetanother aspect, the continuum of care can range from immobile, topartially mobile, to fully mobile. In still another aspect, the methodcan further include comparing the data to data from a device in anothersegment of the continuum of care. In one aspect, the data from a devicefrom another segment can be gait data collected from a leg wornactuator. In another aspect, the data can be gait data collected fromfull mobility measurement system. In a further aspect, the recommendingstep can permit connection of alteration of a parameter of thedifferential air pressure system or user gait change to real timefeedback.

In general, in one embodiment, a self-contained biometric sensor systemfor detecting motion of a user on a treadmill including an enclosure, apair of sensors supported by the enclosure and positioned such that whenthe housing is coupled to a treadmill a portion of the tread is withinthe detectable range of the pair of sensors, and a processor incommunication with the pair of sensors and having computer readableinstructions to receive and process an output from the pair of sensorsand to perform calculations related to obtaining gait parameters basedon the input from the sensors.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the processor can be adapted and configured toprovide clock signal synchronized sensor output data from the pair ofsensors. In another aspect, the sensors can be IR sensors, optical mousesensors, laser sensors, proximity sensors, or light sensors. In afurther aspect, the self-contained biometric sensor system can furtherinclude a display in communication with the processor. In an alternativeaspect, the display can be a PC, a tablet or a smart phone. In yetanother aspect, the display can further include a computer readable codeadapted and configured to determine one or more gait parameters based onthe processor output. In still another aspect, communication with thedisplay can be wired or wirelessly. In one aspect, the self-containedbiometric sensor system can further include an accelerometer attached tothe treadmill and configured to provide an output to the processor. Inanother aspect, the self-contained biometric sensor system can furtherinclude an acoustic sensor positioned to detect a footfall sound andconfigured to provide an output to the processor. In a further aspect,the self-contained biometric sensor system can include the processorcomputer readable instructions for providing a real-time measurement ofa plurality of gait parameters for a user on the treadmill. In analternative aspect, the plurality of gait parameters of a user on atreadmill can be one or more of speed, cadence, left/right stridelength, left/right stride time, foot placement phase asymmetry andstride time jitter.

This and other embodiments can include one or more of the followingfeatures. In one aspect, gait measurement or parameters can be providedto the system from a self-contained biometric sensor system thatprovides accurate, real-time measurement of a plurality of gaitparameters of a user on a treadmill within the range of the sensors ofthe system.

In general, in one embodiment, a system for providing differential airpressure assisted gait training includes a differential air pressuresystem comprising a computer controller, a gait measurement system incommunication with the controller, and a display in communication withthe computer controller adapted and configured to provide real-timefeedback to a user of the differential air pressure system.

In another aspect, the gait measurement system can be a self-containedbiometric sensor system having a computer controller adapted andconfigured to collect gait data. In a further aspect, there are computerreadable instructions in the computer controller of the self-containedbiometric sensor system which provides drawing edits on a display. In analternative aspect, the computer readable instructions in the computercontroller which provides for visual indicia on top of a video output.In yet another aspect, the display can be adapted and configured toimplement user provided drawings using a touch screen. In one aspect,the display or a touch screen in communication with the systemcontroller can be within reach of the user. In another aspect, the realtime feedback to the user of an integrated gait training system can beprovided in a representation including a graphic feedback as to theuser's gait symmetry. In a further aspect, the real time feedback to theuser can be a display of synthesized data. In an alternative aspect, thesynthesized data can be triggered from another data stream. In yetanother aspect, the synthesized data can be processed data bymanipulating one or more data streams. In still another aspect, thesynthesized data can be calculated data by comparing or relating two ormore data streams. In one aspect, the synthesized data can furtherinclude using algorithms to produce outcomes of one or more datastreams.

In another aspect, during a user's operation of an integrated gaittraining system a display output can be changed by a trigger from asensor or component in a gait measurement system. In a further aspect,the display output can be changed to provide an indication of the user'sDAP assisted force asymmetry data. In an alternative aspect, the displayoutput can be changed to provide an indication of the user's DAP cadenceasymmetry data. In yet another aspect, the display output can be changedto provide an indication of the user's DAP upper body phase coordinationdata.

In still another aspect, the display output can be changed. In oneaspect, the real time feedback can include an arrow oriented to indicateto the user an indication of a detected force asymmetry. In a furtheraspect, the real time feedback can include an arrow oriented to indicateto the user an indication of a detected cadence asymmetry. In analternative aspect, the real time feedback can further include an arroworiented to indicate to the user an indication of a DAP assisted forceasymmetry data.

In yet another aspect, the gait measurement system can further include acamera, a ground force sensor, an inertial sensor on the user's leg, andan inertial sensor on the user's hips. In still another aspect, the gaitmeasurement system can further include an EEMG sensor and an inertialsensor. In one aspect, the gait measurement system can further include auser sensor In another aspect, the user sensor can be on or implanted ina user. In a further aspect, the user sensor can be an instrumented or amarked article worn by the user. In an alternative aspect, the usersensor can be a prosthesis, an exoskeleton, an active EEM, a passiveEEM, a biofeedback device, an instrumented or marked pair of shoes, aninstrumented or marked pair of pants, an instrumented or marked shirt,an instrumented or marked article worn by the user. In yet anotheraspect, an equipment sensor can further include a belt sensor, a forcesensor, a feet tracking sensor, or a self-contained biometric sensoradapted and configured to obtain gait parameters. In still anotheraspect, the gait measurement system can further include a user sensorand an equipment sensor.

In one aspect, the gait measurement system can further include a videocamera. In another aspect, the gait measurement system can include oneor more of an instrumented treadmill, a biological sensor for muscleactivity, and a video system for monitoring and analyzing gaitmechanics.

In a further aspect, the system can further include an output device forcommunication to a user of an integrated unweighting training systemthat can be one or more of a visual output device, an audible outputdevice or a tactile device.

In an alternative aspect, the gait measurement system can provide auser's left and right heel strike data and a user's hip rotationaccelerometer data to the computer controller.

In yet another aspect, an output of the computer controller sent to thedisplay can provide an indication of DAP upper body phase coordinationdata. In still another aspect, the gait measurement system can provide auser's left and right load cell contact time data and the matching beltspeed data to the computer controller. In one aspect, an output of thecomputer controller sent to the display can provide an indication of DAPcadence asymmetry data. In another aspect, a user's left and right loadcell force data can be matched with a clock signal data in the computercontroller. In a further aspect, an output of the computer controllersent to the display can provide an indication of DAP assisted forceasymmetry data. In an alternative aspect, the differential air pressuresystem can include a category 1 system, a category 2 system, or acategory 3 system. In yet another aspect, the gait measurement systemcan be adapted and configured to monitor and provide data related touser force asymmetry, user cadence asymmetry or user upper body phasecoordination. In one aspect, processing can include applying a patientspecific factor, a calibration factor or a metric associated with theuser to a portion of the data stream. In another aspect, the collecteddata can include left and right load cell force data matched with aclock signal to provide an indication of DAP assisted force asymmetrydata.

In a further aspect, the DAP assisted force asymmetry data can beprovided to the display or a feedback indicator. In an alternativeaspect, the display output can be based on or representing a portion ofthe limbs of the user within the differential air pressure system. Inyet another aspect, the display output can further include markings toindicate desired gait motion. In still another aspect, the displayoutput can further include a real time overlay. In one aspect, thedisplay output can be triggered by an equipment sensor or a sensor wornon the user. In another aspect, the display output can be a triggeredlimited time duration video. This and other embodiments can include oneor more of the following features. In one aspect, feedback provided to auser can further include one or a variety of types of biofeedbackproviding in conjunction with the integrated gait therapy system. Inanother aspect, the biofeedback can be an audible feedback signaltriggered to when a user is to perform a move.

In a further aspect, the biofeedback can be an electronic stimulationsequence that starts a muscle firing sequence in the user. In analternative aspect, the biofeedback can be a visual cue and an audiblesensory stimulator triggered in synchrony with the therapy performed bythe integrated unweighting and gait training system. In yet anotheraspect, biofeedback can include the stimulation of designated andassociated action groups to help with training of a targeting musclegroup. In still another aspect, providing biofeedback can include a stepof causing electronic stimulation controlling one or more muscle groupsas well as mechanical apparatuses that work to augment the function ofone or more muscle groups the stimulation. In one aspect, the targetedstimulation area can be a muscle group. In another aspect, the targetedmuscle group can be a tendon group or area. In a further aspect, whileraising a leg activating a vibrator acting on a flexor and associatedtendons in the lower hamstring area of the leg. In an alternativeaspect, the biofeedback can include providing on or more sensorystimulators triggered in synchrony with the therapy. In yet anotheraspect, the sensory stimulator can provide an electrical stimulation, avibration stimulation or another tactile stimulation. In still anotheraspect, the therapy can include feedback for force, cadence or phasecoordination. Wherein the therapy includes training for desired cadence,training cadence or footfall pattern.

In general, in one embodiment, there is a patient worn data sensor, suchas for example a shoe based sensor system for collecting and storing ortransmitting data appropriate to the type of sensor to the integratedunweighted gait training system In one aspect, the integratedunweighting gait system receives the patient worn sensor data andintegrates the patient worn sensor data from or collected by the patientworn sensor into a feedback loop to unweight a patient to achieve adesired gait. Thereafter, optionally, is the step of capturingadditional patient worn sensor data. Thereafter the step of providing abiofeedback signal to the user based upon patient worn sensor inputs isperformed when the user is using the patient worn sensor in anenvironment outside of the integrated unweighting gait training system.Thereafter, in some embodiments, there is a step of during an additionalunweighted training session the patient worn sensor data from anenvironment outside of the integrated unweighting gait training systemis used as part of the data in a subsequent unweighted gait therapytreatment session. In one specific exemplary aspect the patient wornsensor is a shoe sensor. In other exemplary embodiments, the patientworn sensor is any of the patient worn sensors described herein or as isappropriate for any of those listed in FIGS. 2, 3A, 3B, and 15, forexample.

This and other embodiments can include one or more of the followingfeatures. In one aspect, the feedback loop can further include providingbiomechanics feedback to the user for biomechanics modification.

In still other variations to an integrated gait training system, thegait measurement or parameters are provided to a controller or processorthe integrated gait training system from a self-contained biometricsensor system that provides accurate, real-time measurement of aplurality of gait parameters of a user on a treadmill within the rangeof the sensors of the system. In one aspect, the plurality of gaitparameters of a user on a treadmill are: speed, cadence, Left/RightStride Length, and Left/Right Stride Time. In stil other aspects, theplurality of gait parameters of a user on a treadmill further comprisingfoot placement phase asymmetry and stride time jitter.

In still another aspect there is provided a method of determining treadbelt speed using an embodiment of the self-contained biometric sensorsystem described herein. In one specific embodiment, the sensors of theself-contained biometric sensor system are positioned over the treadmillbelt so that reflectivity of the belt surface under the sensor(s) can bemeasured. In one specific embodiment, the sensors are an infraredemitter/detector pair (sensor). Next, applying a strip of reflectivematerial of a precise, known length to the treadmill belt. The applyingstep is performed so that reflectivity of the belt surface changesdramatically while the strip is under the sensor. The type of strip andplacement will vary depending upon the specific sensor type andplacement on the treadmill. Next, using sensor output signals inconjunction with microprocessor clock timestamp a period of highreflectivity is used to determine the treadmill speed. In one example,if a one-foot strip of reflective material takes one second to passunder the sensor, the speed of the tread belt is 1 foot/second, orapproximately 0.68 miles per hour. In further embodiments configured forhigher treadmill speeds, once the system has been calibrated to theknown length marker, front to front or rear to rear edge detection canalso be used for greater accuracy for a given sampling rate. The methodmay further include input from a foot fall or foot impact sensor such asan accelerometer, load cell or acoustic sensor.

This and other embodiments can include one or more of the followingfeatures.

In one aspect, the operations of the integrated system during a usertherapy session can include at least one user action recommendation orsystem control function related to using synthesized data.

In another aspect, the at least one action related to control usingsynthesized data can include the use of DAP system data or gait systemdata triggered from another data stream.

In a further aspect, the at least one action related to control usingsynthesized data can include the use of processed DAP system data orgait system data by manipulating one or more data streams.

In an alternative aspect, the at least one action related to controlusing synthesized data can include the use of calculated DAP system dataor gait system data produced by comparing or relating two or more datastreams.

In yet another aspect, the at least one action related to control usingsynthesized data can include the use of algorithms to produce outcomesof one or more DAP system data streams or gait system data streams

In general, in one embodiment, a method of providing integratedunweighting assisted gait training for a user having impaired walkingbiomechanics includes unweighting the user in an appropriate unweightingsystem, performing a therapy routine with the user, collecting dataunder control of a controller or a computer processor of the appropriateunweighting system from a plurality of components of the integrateddifferential air pressure system during the unweighting step and theperforming step, and analyzing one or more of the output data from thecollecting step to determine whether to adapt the performing step.Thereafter, determining to adapt the performing step wherein an adaptivestep or an adjustment step comes from a therapist, from the system or aspart of a data controlled therapy. In still other aspects, the step ofanalyzing is done by person or by the controller of an unweightingsystem. Still further, after the analyzing step, optionally, therefollows a step of continuing the performing step without adapting thetherapy routine. Still further, after the analyzing step there follows astep of continuing the performing step after adapting the therapyroutine. Other optional steps include: providing the user with feedbackregarding how the user's impaired walking biomechanics are changing;repeating the unweighting, performing, collecting and analyzing steps toprogressively re-train the user for walking or running with properbiomechanics; or repeating the unweighting, performing, collecting andanalyzing steps to progressively proceed from a partial unweightingenvironment during the unweighting step to a full weight bearingenvironment during the unweighting step.

In one aspect, the unweighting step can be adapted and configured toprovide a partial unweighting environment specific to the rehabilitationof a patient diagnosed with a disease or an injury. In another aspect,the unweighting environment can be adjusted to achieve a symmetricalwalking pattern for the patient. In a further aspect, the unweightedenvironment can be adjusted by the user. In an alternative aspect, theunweighted environment can be adjusted by the differential air pressuresystem according to a predetermined protocol. In yet another aspect, thecollecting step can be initiated by detecting a heel strike andtriggering a video stream capture. In still another aspect, the videocapture can run for a set time limit. In one aspect, a loop recorder canbe used in conjunction with a high definition video stream. In anotheraspect, the collecting step can further include using a timing offset totrigger the capture of a portion of the high definition stream in theloop just prior to the heel strike reading. In a further aspect, thecollecting step can further include storing the data stream that,optionally, can be stored for an additional timing factor after heelstrike. In an alternative aspect, there is a step of cutting down thesize of the collected video stream to that portion synchronized with atrigger event. In yet another aspect, there is a step of providing oneor more of visual feedback, audible feedback or tactile feedback basedon the analyzing step. In still another aspect, the providing step canbe performed by a therapeutic stimulator. In one aspect, the providingstep can be performed by a tactile stimulator, an electrical stimulationor a vibration triggered in synchrony with the therapy.

In still other aspects of the various embodiments described herein, thesystem processor or controller of an integrated gait training system orthe processor of a self-contained biometric sensor system containscomputer readable instructions adapted and configured according tosystem configuration for receiving, collecting and processing asappropriate under a common time stamp the data provided from themultiple data streams of the integrated gait training system or theself-contained biometric sensor system.

In still further additional aspects, the system processor or controllerof a gait training system or the processor of a self-contained biometricsensor system is adapted and configured for collection of simultaneous,synthesized data from one or more components of the gait training systemor the self-contained biometric sensor system. In some further aspects,the integrated gait training system includes an unweighting system. Inone embodiment, the unweighting system is a differential air pressureunweighting system. In still another embodiment, the unweighting systemis a non-differential air pressure unweighting system. In still furtherembodiments the non-DAP unweighting system is a support frame typenon-DAP unweighting system or a curved arch type non-DAP unweightingsystem, or an unweighting arch type non-DAP unweighting system, or amonocolumn type non-DAP unweighing system or a cantilevered type non-DAPunweighting system.

In still other aspects of the various embodiments described herein, thesystem processor or controller of an integrated gait training system orthe processor of a self-contained biometric sensor system containscomputer readable instructions adapted and configured for storing, in acomputer readable database stored within or accessible to the processor,the collected, synchronized or synthesized data of the unweightingsystem and the gait system. In some aspects, the collected, synchronizedor synthesized data includes, depending upon system configuration andtherapy performed data of one or more of: pressure setting and control,calibration data, system type, auxiliary systems, exercise systemcontrols, video, user worn sensor or equipment sensor, synthesized datatriggered from another data stream, synthesized data from processed datafrom manipulating one or more data streams, synthesized data calculatedby comparing or relating two or more data streams, or, optionally,synthesized data obtained using algorithms to produce outcomes of one ormore data streams. In still other aspects, collected, synchronized orsynthesized data is displayed, output or provided to provide real-timefeedback to a user of the system. In still further aspects, there arecomputer readable instructions for synthesizing the system byintegration of independent data streams collected into another set ofdata or stream of data used in conjunction with the therapy or trainingperformed using the system. In still other aspects, collected,synchronized or synthesized data is derived from the type of patientreceiving therapy and the specific system selected for his patientcategory (i.e., class 1, 2 or 3). In some aspects, the type of patientor system is one factor in determining the type of data synthesisapplied to a specific patient therapy session or course of therapy. Instill other aspects, collected, synchronized or synthesized data fromone component is used to indicate the relevance of a subset of data fromanother component or source. It is to be appreciated that the resultingdata or data stream can be presented in real time, or packaged in a wayto inform another person or system or process of the state of thepatient.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe examples that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is an exemplary method of providing therapy for a patient using adifferential pressure system having measured gait feedback capabilities.

FIG. 2 is an exemplary data collection table or summary of data inputsin an exemplary integrated differential pressure control system havinggait measurement capabilities.

FIG. 3 is an isometric view of a differential air pressure trainingsystem having integrated gait capabilities and a performance feedbackmonitor.

FIG. 3A illustrates the system of FIG. 3 with a GaitBox shown inposition on the treadmill frame.

FIG. 4 is an exemplary specific workflow of a therapy and trainingprocess.

FIG. 5 is an exemplary multi-sensor data stream and synthesis flow forthe workflow described in FIG. 4.

FIG. 6 is a specific patient training example for the system andtechnique described in FIGS. 3 and 4.

FIG. 7 is a flowchart of one alternative outcome based on the adapttherapy step from the method of FIG. 1.

FIG. 8 is an isometric view of an exemplary system using multiple gaitanalysis tools to provide real-time feedback on a display to a patient.

FIG. 9 is an exemplary data collection, synthesis and informationprocessing flow for the system of FIG. 8.

FIG. 10 is an exemplary work flow.

FIG. 11 is a specific patient example using the work flow and method ofFIG. 9.

FIG. 12 is an additional alternative process for adjusting gait therapy.

FIG. 13 is an additional alternative process for adjusting gait therapyin a differential air pressure training environment.

FIG. 14 is an additional alternative process for adjusting gait therapyin a differential air pressure environment.

FIG. 15 is an isometric view of a differential air pressure trainingsystem have additional gait data measurement devices.

FIGS. 16 and 17 are information collection and work flow examples forthe use of the system in FIG. 15.

FIG. 18 is a specific patient example for the use of the system in FIG.15 using the methods and work flow of FIGS. 16 and 17.

FIG. 19 is an isometric view of a differential air pressure trainingsystem have additional gait data measurement devices.

FIGS. 20 and 21 are information collection and work flow examples forthe use of the system in FIG. 19.

FIG. 22 is specific patient example for the use of the system in FIG. 19using the methods and work flow of FIGS. 20 and 21.

FIG. 23 is another illustrative therapy method of using differential airpressure assisted training using gait measurements and physicaltherapist analysis to adapt therapy.

FIG. 24 is another illustrative therapy method of using differential airpressure assisted training where therapists determine appropriatemulti-sensor synthesis and therapy, with display of synthesized realtime feedback, plus adjustments to therapy that are controlled by thephysical therapist.

FIG. 25 is another illustrative therapy method of using differential airpressure assisted training where therapists determine appropriatemulti-sensor synthesis and therapy, displaying synthesized real timefeedback that is data controlled.

FIG. 26 is an example of a two element data synthesis in an integrateddifferential air pressure and gait training system.

FIGS. 27-29 are examples of two element data synthesis in an integrateddifferential air pressure and gait training system that also include adisplay with optional additional feedback that is visual, audible ortactile.

FIG. 30A illustrates a perspective view of a GaitBox.

FIG. 30B illustrates a schematic.

FIG. 31A, 31B and 31C illustrate normal and exemplary gait abnormalityfoot fall patterns.

FIG. 32 is a flow chart of one a technique for biometric factorcalculations.

DETAILED DESCRIPTION

There are available differential air pressure systems suited to trainingusers or patients in different categories based on a number of factorssuch as, for example, patient ability to access the machine, thespecific training needs of the patient and the physical capabilities ofthe patient as well as whether the patient requires assistance duringtraining and if so to what degree. For purposes of discussion, threebasic categories will be used. Category 1 is healthy athletic with noassistance required. Category 2 is moderate assistance (post-surgicalrecovery) where the patient can stand in the system with assistance andremain upright. Category 3 patients require assistance foringress/egress as well as support during therapy. A number ofdifferential air pressure systems for various levels of patientassistance before, during or after use are described in thenon-provisional patent application entitled “Differential Air PressureSystems and Methods of Using and Calibrating Such Systems for MobilityImpaired Users” application Ser. No. 13/423,124 filed on Mar. 16, 2012(“the '124 application”). The entirety of this application isincorporated herein by reference.

While desiring not to be bound by theory, it is believed that apatient's biomechanics will change as a result of unweighting in adifferential air pressure system due to reduced pain or need for legstrength that the user may not possess due to injury, age, or illness.Further, a patient in such an unweighting environment has greaterability to intentionally change their biomechanics and gait patterns inresponse to feedback as compared to the ability to change gait patternsin a full body-weight loading environment. This enhanced ability of apatient to modify gait patterns in a differential pressure unloadingenvironment is a core distinction of the current invention. Due to thegreater ability in such an environment to modify gait, therapy in suchan environment can be more effective than in other environments whencombined with gait measurement systems and feedback systems than suchgait training could be without those measurements and feedback systemsand can be more effective than training with such feedback in afull-weightbearing environment in which the patient is less able tomodify gait patterns. Achieving proper mechanics is an important aspectto proper rehabilitation of gait and motor training. Embodiments of theinvention described herein provide systems and methods that are suitedto the integration of measurements of gait and biomechanics with levelof unweighting. Still further, aspects of the inventive methodsdescribed herein provide for specific rehabilitation protocolsintegrating biomechanics measurements with unweighting which arebelieved to provide more effective and more precise rehabilitation ascompared to conventional visual assessments by the therapist or patientduring unweighting rehabilitation and more effective and more preciserehabilitation than with biomechanics measures in a full bodyweightenvironment or alternate unweighting environment such as a pool orharness in which gait mechanics are significantly altered by theunweighting system.

This application will describe the integration of one or more gaitmeasurement systems for use with a differential air pressure system.Integrated training systems such as these will provide a greater varietyof controlled training and therapy for patients of all patientcategories. Impairment to a patient's ability to complete or participatefully in gait training may come from a number of sources. For example, apatient with a neurological disorder may have motor impairment alongwith muscle weakness. One aspect of off-loading a patient using theinventive systems described herein permits the use of differentialpressure assistance to unload the patient to reduce the impact of theimpairment due to weakness. In another example, a patient recoveringfrom orthopedic surgery may experience pain when exercising with fullweight. While this patient may physically be able to modify their gaitat full weightbearing where a weak patient may not, the reduction ofpain allows for the patient to mentally cope with some necessarymechanical corrections that need to be made. Another aspect ofoff-loading a patient using the inventive systems described hereinpermits the use of differential pressure assistance to unload thepatient to reduce the impact of the impairment due to pain. These aretwo examples of how a DAP system with integrated gait capabilities canassist in controllably and reliably removing common barriers to gaittraining.

Embodiments of the present invention provide for the integration of apressure assisted unweighting environment with biomechanics and gaitmeasurements and a range of therapies for gait improvement. Gaittraining and biomechanics are commonly evaluated in order to assesswalking and running dynamics and to assist patients or athletes inimproving their mechanics. Embodiments include a range of devices suchas instrumented treadmills, biological sensors for muscle activity, andvideo systems for monitoring and analyzing gait mechanics. One or moreof these gait measurement systems are training devices that areintegrated with a differential air pressure system to provide acontrolled, repeatable unweighting environment for gait and walking orrunning mechanics. Embodiments of the present invention provide a systemto retrain individuals to improve or alter walking or running mechanicsby unweighting the individual in a differential air pressure environmentand simultaneously measuring one or more parameters of gait orbiomechanics such as stride length, ground reaction force, lateralmovement of knees, angles of knees and ankles, forefoot or heel strikeparameters, muscle activation patterns, or movement symmetry.

In many patients, the parameters described above are suboptimal at fullweightbearing walking or running. For example, a patient with recentorthopedic surgery in one lower limb, such as total knee arthroplastywill typically walk with asymmetric motion. In an unweightingenvironment, such a patient can walk with greater symmetry due toreduced pain. Retraining symmetry in walking can be important inspeeding the recovery of function in such a patient and reducing risk offuture injury due to the asymmetry of gait in such a patient.Embodiments of the differential air pressure assisted gait trainingmethods herein provide an effective method of retraining symmetry ofmechanics and gait to enable the patient to practice walkingsymmetrically, providing feedback to the patient when such symmetry isachieved and when it is violated.

One specific aspect of treatment using this methodology is to unweightthe patient and measure biomechanics, determine at what level ofunweighting the desired mechanics of gait and motion can be achieved,and then provide feedback to the patient, athlete, trainer or physicaltherapist on an ongoing or periodic basis. Such feedback would enablerecognition of proper mechanics and would reinforce more time walking orrunning with proper mechanics. More time spent walking or running withproper mechanics would retrain muscles in proper motion and would driveneuroplasticity to train such proper motion. Over time, as the desiredgait mechanics are achieved with more consistency, the amount ofunweighting may be progressively reduced in order to acclimate the userto walking or running in this new method of gait patterns until suchpatterns are set as new biomechanics at full gravity.

In still further additional treatment methodologies, electricalstimulation of muscles, braces to align joints, powered exoskeletalsupport, and other established gait training and muscle training methodsmay be integrated into progressive unweighting and reloading protocolsto facilitate the gait training. These standard methods of gait trainingmay be more effective when modified for performance in an integratedgait and differential air pressure environment of unweighting, whereproper biomechanics can be achieved more readily for patients than in afull gravity environment.

In one aspect there is provided a differential air pressure and gaittraining system to improve gait training in patients with impairedbiomechanics by enabling the patient to walk or run in a partialunweighting environment with feedback regarding how the patient'sbiomechanics are changing, so that the patient can retrain walking orrunning with proper biomechanics and then gradually apply this newtraining progressively back to a full weightbearing environment.

In another aspect, there is provided a differential air pressure andgait training system that enables exercise and rehabilitation ofpatients from disease or injury in a partial unweighting environmentwith biomechanics and gait feedback to reduce risk of further injury andto enable improvement of the rehabilitation protocols. In one specificexample, a patient with hip fracture could exercise and walk throughtheir rehabilitation program at the right level of unweighting to enablesymmetrical walking so that they learn to walk properly, rather thanlearning to walk in a manner that compensates for the injured side andtherefore exposes the patient to progressive further injury due to theasymmetrical walking pattern.

FIG. 1 is an exemplary method of providing therapy for patient using adifferential pressure having measured gait feedback capabilities.

First, with an understanding of the different types of differentialpressure systems available, the patient type to use the system, and thedesired therapy to be performed, select an appropriate system to performtherapy with a user. A number of systems types for categories 1, 2 and 3are provided in the '124 application. A category 1 system includes forexample FIG. 2A of the '124 application. A category 2 system includesfor example FIG. 7A of the '124 application. A category 3 systemincludes for example FIGS. 1A and 19 of the '124 application.

Next, customize the system to this patient. Customization may take onmany forms such as based on the specific type or configuration of thedifferential air pressure system being used, personal calibrationtechniques, or inputs of specific patient parameters, or protocols orpatient specific training goals.

Next, the user performs the therapy in the system according to the inputprogram or protocol.

Next, the system will collect gait and differential pressure and othersystem parameters while therapy is ongoing.

Next, the system will analyze the collected data.

Next, determine whether to adapt the therapy based on the prior analysisstep. One result of this step is to adapt the therapy and continue toperform the therapy as adapted. Another result is to continue to performtherapy without adapting the therapy based on the analysis.

One example of the format of a data table for an integrated differentialair pressure and gait measuring and training device is show in FIG. 2.This representative data system envisions collection and synthesis ofdata from several data streams depending upon the specific configurationof the system being used for therapy. The contents of FIG. 2 (i.e., thedata table or variables collected, controlled, processed or manipulatedby the control system) will vary to the degree needed to includecollection of the various continuous, nearly continuous or segmenteddata streams including synthesized data from the therapy system.

Simultaneous data collection refers to the general process of collectingdata from multiple data streams under a common time stamp. It is to beappreciated that embodiments of the various inventive differentialpressure assisted gait training systems described herein are adapted andconfigured for this purpose. However, the various inventive systems arealso adapted and configured to synthesize the data that is beingcollected from the systems, subsystems, accessories, and sensors asshown in the exemplary data table (See FIG. 2). As used herein,synthesis of data refers to the integration of the independent datastreams collected into another set of data or stream of data used inconjunction with the therapy or training undertaken in the system.Synthesis goes beyond basic data collection in that the data is puttogether to straight-forwardly assist the patient or therapistunderstand the workout from a quantitative standpoint. Data collectionsystems just record data, but do not take steps towards helping apatient or therapist who do not have training or experience with thedirect data being collected. In one alternative, the type of datasynthesis is derived from the type of patient receiving therapy and thespecific system selected for his patient category (i.e., class 1, 2 or3). As such, the type of patient or system is one factor in determiningthe type of data synthesis needed for a specific patient therapy sessionor course of therapy. In still further alternatives, the data collectedfrom one component is used to indicate the relevance of a subset of datafrom another source. In one specific example, there is a cameraproviding a high definition video stream of a post knee surgerypatient's knee movement during therapy. The storage and later processingrequirement for such a high volume of data may be a difficult and timeconsuming task. In one specific example of data synthesis, a forcesensor on a treadmill is used to indicate heel strike and triggers thecapture of a video stream that runs for a set time limit. In anotherspecific embodiment, there is also a loop recorder used in conjunctionwith the high definition video stream. In this example, the heel strikesensor, employed in conjunction with a timing offset, is used to triggerthe capture of a portion of the high definition stream in the loop justprior to the heel strike reading. Thereafter, the data stream is storedfor an additional timing factor after heel strike. During the use ofthis data, the relevant portion of the video is now cut down to andsynchronized with the recording or relevant trigger, here a heel strikereading in this example. FIG. 26 illustrates the selective combinationof heel strike data with video stream data to represent the collectionof frame grab or snippet of DAP and gait data. The data or datasteam canbe presented in real time, or packaged in a way to inform a doctor,therapist, shoe maker, etc. of the state of the patient.

In still another example, a self-contained biometric sensorsystem—referred to herein as GaitBox—is another form of Gait systemsensor that may be employed according to the various Gait techniquesdescribed herein. The GaitBox provides accurate, real-time measurementof basic gait parameters on any treadmill. The basic gait parametersare: Speed (distance divided by time); Cadence (number of steps perminute); Left/Right Stride Length (distance between successive impactsof same foot, e.g. left-foot-impact to left-foot-impact); and Left/RightStride Time (time between successive impacts of same foot). Otheradditional gait parameters include, by way of example and notlimitation, foot placement phase asymmetry (right to left step timecompared with left to right step time) and stride time jitter (variationin timing between subsequent footfalls on the same or opposite sides).

A GaitBox is shown on the treadmill frame in FIG. 3A. Additional detailsof GaitBox as set forth below with regard to FIGS. 30A and 30B.

Other more advanced types of synthesis are also performed by embodimentsof the inventive system. In another exemplary system a data stream thatis being collected may be processed prior to or in conjunction withrecording. Here, processing may take on a number of different forms suchas applying a patient specific factor such as a calibration factor orother metric associated with a specific patient. One example of a kindof data synthesis is shown in FIG. 27. FIG. 27 illustrates how the leftand right load cell force data may be matched with a clock signal toprovide an indication of DAP assisted force asymmetry data. The DAPassisted force asymmetry data is then provided to the user in a simpledisplay or other feedback technique such as the indicator shown on theright side of FIG. 27. The placement of the arrow in the middle is thedesired location. As the user trains, the detected force asymmetry willcause deflection of the arrow. As the patient alters his gait, the arrowmoves in a corresponding direction.

Another example of a kind of data synthesis is shown in FIG. 28. FIG. 28illustrates how the left and right load cell contact time data may bematched with belt speed data to provide an indication of DAP cadenceasymmetry data. The DAP assisted cadence asymmetry data is then providedto the user in a simple display or other feedback technique such as theindicator shown on the right side of FIG. 28. The placement of the arrowin the middle is the desired location. As the user trains, the detectedcadence asymmetry will cause deflection of the arrow. As the patientalters his gait, the arrow moves in a corresponding direction.

Another example of a kind of data synthesis is shown in FIG. 29. FIG. 29illustrates how the left and right heel strike data may be matched witha hip rotation accelerometer data to provide an indication of DAP upperbody phase coordination data. The DAP upper body phase coordination datais then provided to the user in a simple display or other feedbacktechnique such as the indicator shown on the right side of FIG. 29. Theplacement of the arrow in the middle is the desired location. As theuser trains, the detected upper body phase coordination data will causedeflection of the arrow. As the patient alters his body phasecoordination, the arrow moves in a corresponding direction.

Another form of processing may be the application of use factors,calibration settings or auxiliary component settings applied to datastreams based on the kinds of specific systems, auxiliary systems orcomponents utilized in a specific training scenario. In this way, datacan be collected in a raw form as well as with normalization factors tostandardize data collected from different sensors, components or patientsettings. Thusly, data collected for different patients using similarlyconfigured systems but with different components may have data collectedthat will permit the patient specific data to be compared and/oraggregated for wide spread data collection. Consider this specificexample. A normalizing factor would be the factor used where a CAT 2training system with a shoe sensor from vendor A and a post-surgery kneemale in Toledo and a CAT 2 training system with a shoe sensor fromvendor B with a post-surgery knee male in Topeka will each record therespective patient's own raw data but there will be correspondingnormalized data that eliminates the variations (if any) between thesensors from different shoes and different vendors. In a similar way,where needed based on specific circumstances, all or some of thecomponents in the system (See FIG. 2) may be processed such that acommon or normalized data setting may be applied so that when data iscollected from systems with different specific components, the datastreams may include both raw and normalized. In one specific embodiment,the application of one or more normalization factors is one kind of datasynthesis.

In still another type of data synthesis, the data from one or more datastreams may be used in calculations or further processing to yield adetermination or outcome related to the input data streams or accordingto the therapy being undertaken. One example is the use of an algorithmto perform transformations of one or more data streams. The output ofthese functions will be stored along with the other recorded data. Instill another example, an algorithm may include various weightingfactors to a data stream such that some data may be processed in amanner consistent with the type of therapy being delivered. In stillfurther specific examples, a processing algorithm may include fuzzylogic or artificial intelligence using a computer processor adapted andconfigured for that purpose.

Current state of the art therapy uses DAP technology to unweight apatient while the physical therapist provides feedback by viewing thepatient as they work out. Some systems incorporate a video feedbackelement that allows the patient to view themselves from various angles.By using only one type of feedback, there may be optimal treatments thatare left unidentified by the therapist. By integrating multiplemeasurement systems with a DAP system, synthesizing the data streams,and presenting the information in an appropriate way, a therapist wouldhave the ability to utilize information that has only been able to begathered in a laboratory setting in the past. The therapist would havethe ability to then analyze and more effectively set workouts for thepatient to improve recovery time.

FIG. 3, for example, illustrates a patient a using a DAP system withcameras, ground force sensors, and inertial sensors on the user's legsand hips. In this view, the pressure bag that normally covers the frameand defines the pressure chamber is removed to permit the interiordetails of the pressure chamber and the instruments contained therein tobe observed. Throughout the workout, the system takes data about theuser's gait, speed, incline, and effective bodyweight. That informationis synthesized and given to the therapist during or at the end of theworkout. In one alternative, the therapist can then watch a video thatshows the patient's movements, speed, weighting, and the angles of thehips at each point. The therapist can use that information to moreeffectively set the next workout, leading to better recovery times. Dueto the placement of the sensors, biomechanics points such as the user'ships, that are not visible through the enclosure of a current DAPsystem, can be measured, tracked and evaluated.

FIG. 4 illustrates a more specific work flow of the therapy and trainingprocess described. FIG. 5 is an exemplary data stream and synthesis flowfor the above described example. FIG. 6 is a specific patient trainingexample for the above described system and technique of training.

While the method of FIG. 1 provides a general procedure for conductingtherapy using differential pressure and date measurement feedback, thereare alternatives to be provided by the therapy system. These alternativeoutcomes based on the “adapt therapy” step will now be discussed from amanual feedback to a generally increasing automatically controlledfeedback system. It is to be appreciated that while these alternativefeedback mechanisms are described as discrete separate configurations,the system may adapt any or all of these feedback mechanisms for anyparticular user, specific training session, or ongoing therapy protocol.

FIG. 7 describes one alternative outcome based on adapt therapy step. Inthis outcome the system provides an output of results. Next the userwill interpret the output of results. Then, the user makes an adjustmentto the therapy system based on the user's interpretation of the results.Thereafter, the therapy session will continue or be set for the nexttraining session.

FIG. 8 illustrates one exemplary system using multiple gait analysistools and DAP to provide real-time feedback to assist patients andtherapists. In this view, the pressure bag that normally covers theframe and defines the pressure chamber is removed to permit the interiordetails of the pressure chamber and the instruments contained therein tobe observed. To help the therapists identify better treatments,incorporating an analysis aspect into the first system would allow thetherapists to receive real-time input on ways to improve the workoutfrom a quantitative standpoint. The state of the art treatments now useeither video feedback or force sensors with DAP to show the therapist orpatient limited aspects of their gait. By integrating and synthesizingmultiples sensors and measurement systems together, and providinganalysis, the patients and therapists will be able to more accuratelyand thoroughly judge and correct or modify gait in a desired fashion.

That system can be extended to include feedback from other sensors usedto capture gait, workout parameters, other physiological measurements,or psychological elements according to specific system, component,therapy or patient requirements. Integrating data from, for example,EEMG sensors and inertial sensors into understandable information wouldgive a depth of information to a patient or therapist to adjust theirgait with the assistance of unweighting that does not exist today.Further, in a DAP environment, such data is more useful to a patient andtherapist than it would be in a full weightbearing environment becauseof the greater ability of the patient to adjust gait mechanics in theDAP environment. Similarly, the DAP environment permits greater abilityto adjust gait desirably in response to these inputs than does analternate environment such as pools or harness systems in which the gaitmeasurements would be altered by the forces and restrictions placed onthe user by the harness or pool environment and the ability of the userto adjust gait is less in such environments than in a DAP environment.

FIG. 9 illustrates an exemplary data collection and informationprocessing flow for this specific system configuration and therapyexample. FIG. 10 illustrates one exemplary work flow scenario. FIG. 11is one example of a patient specific therapy procedure using the systemand methods above. The patient in this example would likely use acategory 2 or category 3 system as described in the '124 application.

FIG. 12 differs from FIG. 7 in the outcome based on the adaptive therapystep in that the system will now provide a recommendation for gaitcorrection. In this alternative outcome, the system provides an outputor results with a recommended action. Exemplary recommended actionsmight be a biomechanical adjustment for gait correction. For example,the system may indicate for the user to change the orientation of theirfoot, rotate their ankle, bend their knees more, or other adjustmentsthat are based on analysis of the patient gait data to correct or modifythat patient's gait. Another exemplary representative recommended actionwould be for the system to recommend repeating the last gait therapyroutine however at a different amount of differential pressure assist.For example, in one possible embodiment, if a desired gait pattern wereachieved at a certain degree of unweighting, the system could recommendto the patient every few minutes to slightly increase the amount ofloading by unweighting less in order to find the point at which desiredmechanics patterns are no longer maintained. This would permit precisedetermination of the unweighting level needed to train proper mechanicsfor this patient. Other recommended actions are possible based on thespecific patient performance and performance parameters entered into thetreatment system. The user next is allowed to accept or reject therecommended action or to accept with modification the recommended actionfrom the system. Thereafter the system performs the therapy either as anext segment of training or in a subsequent training session.

FIG. 13 differs from FIG. 12 in that the outcome based on the adaptivetherapy step is more automated in the system's response to the usersperformance. Here again the analysis is performed based on the collecteddata and the patient performance. The system analysis will generate anoutput for the system adjustment based on the accepted protocol. Herethis protocol might be for specific postsurgical training, gaitcorrection, or other patient specific therapy endpoints. A significantadvantage to this type of system is that it will be able to modify gaitin ways a therapist could not. As an example, research may show thatattempting to develop a slightly asymmetrical gait in a DAP environmentproduces better results at full weightbearing. The system would be ableto adjust speed, incline, and bodyweight between left and rightfootplants, or plant vs. pushoff stages of walking or running. Atherapist would not be able to control a system that quickly andaccurately, where a fully automated system could. Next, the system willimplement the adjustment to the therapy and the therapy session willproceed in the next segment of treatment or in the next session oftreatment. Optionally, the system's ability to implement an adjustmentto the therapy is limited. This limit is set on the amount that acontrol parameter can change per session or per training incrementduring a session. In this way, the system may be able to only change thesystem parameters within an established safe limit of parameter changefor this patient type, age, previous performance, established protocol,or other safety related parameter for system adjustment.

FIG. 14 differs from FIG. 13 in that the outcome based on the analysisis generated by and automatically implemented by the system. Thisversion of the system provides integrated and automated correction ofgait therapy and differential pressure support parameters based onpatient performance, gait data collection and analysis, and specificinputs of a patient training protocol. Here again the adapt therapy stepis based on the prior analysis of collected data and review of patientperformance and other parameters. The system analysis will generate anoutput for system adjustment based on the patient protocol. The systemoutput and adjustment will be applied to the system during therapy withor alternatively without notice to the user depending upon patientspecific training parameters. Thereafter, the therapy will continueusing the adjusted system parameters.

FIG. 15 illustrates a system using gait analysis tools to directlycontrol workout parameters. In this view, the pressure bag that normallycovers the frame and defines the pressure chamber is removed to permitthe interior details of the pressure chamber and the instrumentscontained therein to be observed. If the analysis of the incoming sensordata is appropriate, the system can be extended to directly controlworkout parameters to automatically optimize a therapy session toimprove specific aspects of gait. The system would take input from thesensors such a EMG, video, inertial, and ground force; then evaluatewhat workout parameters (effective bodyweight, speed, incline, balance,etc . . . ) need to be adjusted to optimally improve the patient's gait.The system can also monitor the gait changes observed during the sessionto determine if the desired improvement is achieved and test alternateparameter settings within allowed ranges while providing feedback to thepatient to assist in guiding patient-directed gait modification attemptswhile measuring the changes in gait patterns made in response to thisfeedback. The feedback loop between the patient, the system's sensors,the changes in workout parameters, and the methods of directing gaitchanges can iteratively interact to enable desired gait modification tobe achieved. This allows a patient to recover more quickly, and allows atherapist to concentrate on other aspects of patient health improvement.

Therapists would be enabled to set bounds for how much the workoutparameters can change, so as not to cause an injury or overwork thepatient. Limitations on particular aspects of the therapy could also beaccessed from a database based on research, a physician'srecommendations based on the procedure or from a database of comparablepatent and/or system configurations therapies and outcomes. Therapistswould also be enabled to set specific desired gait parameter changes ortargets desired so that the feedback process could be directed by thesystem to reinforce and enable incremental improvements toward thedesired gait mechanics patterns.

FIGS. 16 and 17 provide examples of a work flow (FIG. 17) and datastream/synthesis (FIG. 16) for the exemplary system. FIG. 18 providesone specific example of how a system may work is that the therapist setsthe system to improve the pronation of the foot during the push-offphase of walking. The patient in this example would likely use acategory 1 system as described in the '124 application. The therapistalso sets the maximum speed at 2 mph, so as not to cause the patient tostart running. The system will then go through a diagnostic processwhere it changes weight, incline, and effective bodyweight whileproviding audible, visual, tactile or other feedback to the patientregarding the parameter to be modified, determining which combination ofsettings enables the patient to achieve the best pronation of the foot.As the workout goes along and the patient works on improving theirpronation, the unit can incrementally increase the effective bodyweightas a means to eventually train the patient to pronate their foot at fullbodyweight. If the system starts to detect the user is having troublepronating, it can also either slow the treadmill or unweight the patientto a greater degree to give the user more time to pronate the foot orreduce load on the foot to enable better pronation. At the end of theworkout, the therapist would receive a report of how the user progressedand a suggestion for where the next workout should begin.

FIG. 19 illustrates still another exemplary system using gait analysistools, DAP Technology, and biofeedback to train and/or improve gait. Inthis view, the pressure bag that normally covers the frame and definesthe pressure chamber is removed to permit the interior details of thepressure chamber and the instruments contained therein to be observed.With regard to the training technique of FIG. 19, an additional featureis the continuous recording of the electrical activity of the muscles inthe form of electromyograms (EMGs). These are real-time recordings ofthe electrical activity of the muscles measured with surface electrodes,or, optionally, with fine wire electrodes, or with a mix of electrodetypes.

FIGS. 20 and 21 provide examples of a work flow (FIG. 21) and datastream/synthesis (FIG. 20) for the exemplary system. FIG. 22 provides aspecific example for a patient undergoing such therapy. The patient inthis example would likely use a category 3 system as described in the'124 application. In one specific aspect, some patients undergoing gaitcorrection therapies may have suffered an injury that impedes the normalbiological feedback loops that exist in the body. For example, a strokepatient may no longer be able to feel pressure in their right leg assensitively as they feel pressure in their left leg. This will cause anasymmetry in gait that needs to be corrected. Even with gait analysisand automatic workout adjustments, the patient may still have problemsachieving regular gait due to the damage to the biological feedback loopof the patient. In current therapies, the therapist manually adjusts theposition of the patient's legs. In a differential air pressureenvironment, access to the patient's lower body can prove difficult. Byadding some other form of biological feedback being controlled by thesystem, a patient may be able to more rapidly achieve proper gaitmechanics, without the necessity of a therapist manually manipulatingthe legs.

In various alternative embodiments, there may be used one or a varietyof types of biofeedback integrated into a system with gait measurement,analysis, and DAP based upon the specific therapy needs of a specificpatient or class of patient. For purposes of illustration, exemplarytypes of biofeedback may include indicators to give the patient asensation that triggers the patient to act such as an audible alarm whenthe patient needs to lift their leg, an electronic stimulation sequencethat starts a muscle firing sequence to extend the foot, a visual cueand the like. One additional aspect of the embodiment of FIG. 19 is theprovision for the full stimulation of designated and associated actiongroups to help with training of a targeting muscle group. The fullstimulation may be caused by electronic stimulation controlling one ormore muscle groups as well as mechanical apparatuses that work toaugment the function of one or more muscle groups. In one example, thetargeted stimulation area is a muscle group. In another, the targetedmuscle group is a tendon group or area. For example, when the leg isbeing raised, flexor and associated tendons in the lower hamstring areaon the back of the leg are optionally subject to vibration or anothertype of full stimulation. This is thought to strengthen the desirednerve pathways to allow the patient to develop toward over groundlocomotion. Therapeutic stimulators meant to provide sensation mayprovide electrical stimulation or may be vibrator or other tactilestimulators or other sensory stimulators triggered in synchrony with thetherapy, as needed.

EXAMPLES

In one example, a Differential Air Pressure System having gaitcorrection capabilities integrated with a prosthesis or otherproprioceptive feedback or training device. In this specific example,the integration of a differential air pressure system with gaitcapabilities as described above with machine control capabilities,enables feedback or training using muscle memory motion via anassistance device. Additionally or alternatively, there may bemodifications to the control system depending upon the controlrequirements of the type of motion assist device incorporated into theDAP system.

In still another example related to a sensor of the type worn by apatient, the patient may wear shoes having integrated instrumentationsuch as, for example, motion sensors, inertial sensors, force sensorsand the like. The shoe may store the data collected from the onboardsensors onboard for later incorporation and synchronization with othersystem collected data. Additionally or alternatively, the shoe mayinclude transmission capabilities to send data from the shoe to asuitable receiver on the system. In this way, data from the shoe(s) usedby the patient are included into the simultaneously collected datastream as discussed above. In still another embodiment, the shoe sensoris used to record patient activity while outside of the differential airpressure training system described herein. Data may also be collectedfrom sensors worn outside of the DAP training and integrated with thedata collected when using the DAP system with integrated gaitcapabilities. This would for example enable the system to determinedifferences in gait pattern evident while training at partial bodyweight with the sensor data indicating gait parameters in full bodyweight locomotion. Still further there is provided access for collectionof other exercises conducted in support of the patient training. Forexample, a patient conducting strength training in addition to DAP gaittraining may have that training data downloaded or entered along withthe DAP gait training data in order to have a comprehensive data setcollected in the DAP gait system that reflects the patient's entiretraining and therapy effort. For example, a patient with a strokecausing impairment in one leg, may have strength training data in thatleg correlated by the system with gait changes to determine whichstrength training processes are helping to improve gait and to reinforcewhich specific muscle groups need further therapy for flexibility,strength or other parameters in order to achieve desired gaitimprovement.

In one specific example, there is a shoe based sensor system thatcollects and stores or collects and transmits data on various pressurepoints to provide gait instruction while using a system described hereinor performing one of the illustrative methods of therapy. The DAP gaitsystem integrates with the shoe based data collection system in afeedback loop to unweight a patient to achieve desired gait, and thencapture data or, optionally, provide biofeedback based upon sensorinputs when they are off the treadmill in normal activity. In this way,the integrated DAP gait training system becomes part of the treatmentmodality to use unweighting therapy and biomechanics training as part ofthe feedback loop to accelerate biomechanics modification.

In still another specific example, patient uses a differential airpressure system with gait training capabilities to unweight and retrainwhile integrating foot sensor data to achieve desired patterns. Thepatient practices during several thirty minute sessions at slowlyprogressing reloading while maintaining the desired pattern. When thepatient can achieve the desired sensor and biomechanics pattern at 90%of body weight, the patient is provided shoes with the sensors to takehome and use regularly recording the data and feeding back real timedata to a mobile device such as a cell phone, personal data assistant(PDA) or smart phone. The data tracking shows how closely the patient isadhering to the desired walking mechanics achieved in the DAPenvironment and what deviations are monitored. The next session on theDAP gait training system, the gait training protocol uses that data todetermine unweighting and a training program that specifically helpscorrect the poor mechanics tracked in the full weightbearingenvironment. When proper mechanics are achieved in the unweightingenvironment, another series of 30 minute practice sessions using thosemechanics while unweighted with biofeedback to maintain proper gait isprovided to help the patient relearn proper gait mechanics. This patternis repeated several times until the patient reliably and repeatablyadopts the new gait pattern and maintains that pattern in full gravitywalking.

FIGS. 23, 24, and 25 are flow charts of additional patient training workflows using the DAP and gait systems described herein.

The various embodiments of an integrated differential air pressure andgait training described herein also includes a computer controller incommunication with the various system inputs (see, e.g., FIGS. 2, 5, 9,16, and 20) as well as other components for the control and monitoringof the therapy system. In some embodiments, the system receives inputsfrom data collected by GaitBox used with the system. A keyboard and amonitor attached to the system or available during use enables the useror a trainer/therapist to input selected differential air pressure,calibration, kinematic parameters, gait parameters, dynamic steppingparameters and other parameters depending upon patient therapyobjectives and system configurations into the computer-based control andperformance monitor system. The term user, here, covers the patientand/or a therapist and/or a physician and/or an assistant. A userinterface to the system is implemented by a keyboard/monitor setup orGUI screen or touch pad or wireless controller attached to or incommunication with the system control computer. In one aspect, the inputdevice is easily reachable by the patient, as long as the patient hasenough use of upper limbs. It enables the user (therapist or patient) toinput selected kinematic and dynamic stepping parameters, treadmillspeed, differential air pressure and other system specific parametersinto the control and monitor system. A condensed stepping performancecan also be viewed on this monitor interface in real time, based onpreselected performance parameters (see e.g., the display in FIG. 3 orFIG. 8). It is to be appreciated that display in that configuration orin others may be modified to include an externally located digitalmonitor system displays the patient's gait and/or stepping performancein selected details in real time. In one aspect, the display istriggered for collection or display based on other parameters such as inthe heel strike example above for recording a video data stream of kneebend.

In addition, the system control computer includes the components andsub-systems used for a data recording system that enables the storage ofall training related and time based and time coordinated data, includingelectromyogram (EMG) signals among others as illustrated and describedabove in FIGS. 2, 5, 9, 16, and 20. In addition or optionally, thesystem receiver inputs from data collected by or provided from a GaitBoxused with the system. This collected data may be used in real time ornear real time during a therapy session. In still further examples, thecollected data may be stored for off-line diagnostic analysis, therapyadjustment and planning with other patients of similar type. Thearchitecture of the data recording part of the system enables thestorage of all training related and time based and time coordinateddata, including electromyogram (EMG), torque and position signals, foroff-line diagnostic analysis of patient motion, dependencies andstrengths, in order to provide a comparison to expected patterns ofnondisabled subjects. The system will be capable of adjusting orcorrecting for measured abnormalities in the patient's motion. In stillfurther alternatives, the data collected may be normalized to a commondata collection standard for differential air pressure treatment systemsto remove variations in specific equipment, components, measuringdevices and the like. The normalization or standardization of datacollection enables the data collected from one patient to be used toguide the therapy of another patient by showing performance parametersand system configurations.

In one aspect, it is to be appreciated that the integrated DAP systemwith gait measurement may be operated to use differential pressureassistance to selectively and controllably adjust the mechanical loadacting on the patient while optimizing the work or therapy performed bythe patient to provide effective stepping and standing during therapyalong with measurable and repeatable data collection, synthesis feedbackinto specific therapy regimes and protocols.

In still another aspect, the systems and method of gait trainingdescribed herein (optionally including the use of a GaitBox for datacollection) provide a true user controlled gait training environment.The integrated DAP and gait measurement systems of FIGS. 3 and 8, forexample, provide the user or trainer with feedback that permits theimmediate connection of alteration of system parameters or gait changeto feedback. The ability of a user or trainer to see immediately theoutcome of the latest change to system settings or gait modification asimproving, worsening or have no impact is an important link in thetherapy chain as yet unattained by conventional training systems. Thefreedom of range of motion provided by the DAP training system minimizesor reduces the impact of patient off-loading from adverse gait impact.In other words, other patient assist devices such as harness orsuspension systems tend to alter gait artificially rather thanpermitting the uninhibited range of motion afforded in a DAPenvironment.

The GaitBox provides accurate, real-time measurement of basic gaitparameters on any treadmill.

The basic gait parameters are: Speed (distance divided by time); Cadence(number of steps per minute); Left/Right Stride Length (distance betweensuccessive impacts of same foot, e.g. left-foot-impact toleft-foot-impact); and Left/Right Stride Time (time between successiveimpacts of same foot). Other additional gait parameters include, by wayof example and not limitation, foot placement phase asymmetry (right toleft step time compared with left to right step time) and stride timejitter (variation in timing between subsequent footfalls on the same oropposite sides).

FIG. 32 illustrates a method of calculating a variety of factors.

In one aspect, to calculate these values when someone is walking orrunning on a treadmill requires:

An accurate (microsecond resolution) clock

The speed of the tread belt

The time of foot impact, and

Which foot (left/right) impacted the tread deck

In one embodiment, the GaitBox obtains these measurements in thefollowing ways:

Accurate clock—the various sensors are attached to a microprocessorwhich has a regular clock interrupt with 4 microsecond resolution.

Tread Belt Speed—an infrared emitter/detector pair (sensor) ispositioned over the treadmill belt so that reflectivity of the beltsurface under the sensor can be measured. A strip of reflective materialof a precise, known length is applied to the treadmill belt, so thatreflectivity of the belt surface changes dramatically while the strip isunder the sensor. The duration of the period of high reflectivity (asmeasured by the microprocessor clock) gives the treadmill speed. Forexample, if a one-foot strip of reflective material takes one second topass under the sensor, the speed of the tread belt is 1 foot/second, orapproximately 0.68 miles per hour. At higher speeds, once the system hasbeen calibrated to the known length marker, front to front or rear torear edge detection can also be used for greater accuracy for a givensampling rate.

Time of foot impact—an accelerometer is attached to the treadmill frame.When a foot impacts the tread mill deck (which is supported by thetreadmill frame, perhaps with cushioning), the resulting acceleration ofthe deck is transmitted to the frame and sensed by the accelerometer and“stamped” with the elapsed time in microseconds as measured by themicroprocessor clock. An acoustic sensor can also be used to detect forimpacts. Alternatively, a different marker of stride periodicity can beused, such as when each leg passes in front of the proximity sensor orsensors.

Which foot—an infrared proximeter is mounted so that its beam (and hencearea of detection) is directed perpendicular to the direction of belttravel. The “near foot” (closest to the proximeter) interrupts the beamtwice: once briefly, during the swing forward (towards impact) and againwhen the foot is planted on the treadmill, moving backwards. When swingforward is detected, the next impact will be for the “near foot” (leftor right depends on the side to which the GaitBox is mounted).

FIG. 30A is a perspective view of a GaitBox. The GaitBox is an enclosurewith a pair of sensor (S1, S2) positioned in an appropriate location andaspect on the enclosure to obtain information for user calculations asdescribed above. Shown in phantom on the top of the enclosure is anoptional display.

FIG. 30B is an illustration of the functional components of arepresentative GaitBox. The sensors (S1, S2) may be any sensor suited toobtaining the user parameters described herein. Exemplary sensorsinclude IR sensor, optical mouse style laser sensors, proximity sensors,light or other sensors suited for use in the GaitBox operatingenvironment. The processor includes the computer readable instructionsto receive and process the output from the sensors (S1, S2). The processmay provide the outputs listed or other outputs as desired for any ofthe above-described Gait analysis or system implementations. Asillustrated, the processor may provide an output to a display that is onthe GaitBox (see FIG. 30A) or in communication with the GaitBox. Thedisplay may be separate from the GaitBox and any associated exerciseequipment or Gait processing system or it may be integrated into theseother systems. The GaitBox also includes one or more of typicalcommunication modes based on the desired operations or use of theGaitBox outputs.

It is to be appreciated that one or more of the GaitBox characteristics,functions or capabilities may be used to provide inputs/outputs or otherinformation to enhance the operations of the various Gait techniques asshown and described herein.

Visual Display

The basic visual display of the GaitBox may be on the GaitBox (FIG. 30A)or provided as an output to a dedicated device or to a display that ispart of the exercise equipment or Gait system used in cooperation withGaitBox. In general, the visual display presents the followinginformation:

Elapsed Time (updated every second)

Elapsed Distance (updated every second)

Elapsed Steps (updated every step)

Average values for

-   -   Speed (total distance/total time—updated once a second)    -   Cadence (total steps/total time—updated every step)    -   Left/Right Stride Length (total length of strides on given        side/total time—updated after each stride)    -   Left/Right Stride Time Percentage (total time of strides on        given side/total time—updated after every stride)

Instantaneous values for

-   -   Speed (current speed reading)    -   Cadence (based on the duration of the last step—updated after        every stride)    -   Left/Right Stride Length (length of last stride—updated after        every stride)    -   Left/Right Stride Time Percentage (duration of stride on given        side/duration of last two strides—updated after every stride)

As mentioned above, the visual display can be presented via nativesoftware running on a PC, a tablet, or a smart phone, i.e. a softwareapplication designed to run on one or more of these platforms). Althoughthe microprocessor in the GaitBox itself may do some processing of theraw sensor date (e.g. noise filtering or error correction), the actualdata display is performed by the software application running on thedisplay device. We will refer to this as the “GaitBox application” (asopposed to the GaitBox hardware, consisting of the sensors andmicroprocessor).

As shown in FIG. 30B, the Gaitbox will communicate with the displaydevice wirelessly via Bluetooth or Wi-Fi, although other implementationscould use a wired connection such as Ethernet or RS-232.

Video

In an alternative embodiments or in addition, the GaitBox systemincorporates one or more video cameras, which can communicate with theprocessor and/or as well as visual display in either a wired or wirelessconfiguration. In one aspect, the visual display will show the video inreal time. In some configurations, the video may appear on a separate“page” which can be selected by the user, or alongside other informationon the primary screen. If multiple cameras are available, the GaitBoxapplication provides for selection of the camera to be displayed. Insome embodiments, a GaitBox application provides for simultaneousdisplay of multiple camera views.

Visual Feedback

In some aspects, the computer readable instructions in the applicationwhich manage the visual display provide for drawing edits such as linesand shapes (e.g. rectangles or circles) or other visual indicia on topof the video. These user provided drawings may be implemented using atouch screen, for example.

In addition to the basic gait parameters, the application which managesthe visual display may provide graphic feedback as to the symmetry ofgait. For example, two bars (representing left/right stride length)might appear on the display, and the user instructed to make the twobars equal in length (and of a specific height, i.e. stride length).

Reporting

The GaitBox application includes computer readable instructions togenerate a summary report (total time, total distance, total steps,average speed, average cadence, and statistical measures of left/rightstride length and time percentage (min/max/mean/median/standarddeviation) or any other collected parameter, calculated parameter in anycombination or as specified by a user. In addition, the report may bepreserved in some fashion either on or off the display system (e.g.printing, stored as a file, or e-mailed).

User Identification

Some versions of the GaitBox application will allow the user to identifythemselves. For example, on a smartphone the Gaitbox application mightbe used to scan the QR code from a membership card. A PC-basedimplementation of the GaitBox application might recognize an RFID chipor incorporate a fingerprint scanner. Once identified, the gaitinformation collected by the GaitBox application (including video, insome implementations) would be associated with that user.

Data Storage

Some implementations of the GaitBox application will allow the resultsof a session to be saved locally. Some implementations will allow theinformation to be saved on a server on the Internet. Data storage may beperformed using any of the communication modes available (see FIG. 30B)or via USB, firewire or other physical data port provided on a GaitBox.

Web Access

If GaitBox session data is saved to a server on the Internet, aWeb-based application will make that information available via abrowser. If information is associated with a particular user, they willhave the ability to see only the information from their own sessions.

While the various Gait techniques and systems and the GaitBox are shownin use and configured for providing therapy utilizing DAP systems, thevarious embodiments of the present inventions are not so limited. Thegait methods and systems described herein, particularly for the GaitBox,may be adapted and configured for use with a treadmill with (asdescribed) or without a DAP or other assisted use device.

In addition to the above described, techniques, other variations ofimplementing the system are possible. In one example, at low walkingspeeds, detecting a foot strike with an accelerometer mounted to thetreadmill deck is challenging, due to the amount of background vibrationinduced by the treadmill motor itself. An alternate embodiment is to usean acoustic microphone alone or in conjunction with any of the abovedescribed aspects to detect foot strikes. In still another alternativeembodiment, the detection of foot strikes is neglected altogether andinstead leg proximity sensors are employed to measure the intervalsbetween successive passages of the legs in front of the sensors.

To capture more complete workout data, the present invention can alsocapture user's heart rate and treadmill incline through wireless heartrate monitoring sensors and gyroscopic or accelerometer sensors

In situations where patients progress through a continuum of care, fromimmobile, to partially mobile, to fully mobile, gait data generated bythe current invention can be connected and compared with data fromdevices aimed at other segments of the care continuum. An example mightbe gait data collected from a Tibion bionic leg matched against datacollected from the present invention, compared to gait data collectedfrom full mobility measurement system such as those produced by Optogaitor Zebris. Doing so allows showing efficacy of treatment over time,beyond the range of any single system.

The current invention enables the measurement of gait asymmetry throughthe use of leg proximity sensor mounted on either side of the treadmillby reference to FIGS. 31A-31C. FIG. 31A is a normal symmetrical stride.FIG. 31B and 31C illustrate two kinds of gait abnormality, phaseasymmetry (FIG. 32B) and stride jitter (FIG. 31C). In FIG. 31B A iscompared to B. In FIG. 32C, A1 is compared to A2.

In still further aspects, the Gait methods and systems described herein,in particular the GaitBox embodiments, may be used in conjunction withother unweighting devices or systems. Exemplary non-DAP basedunweighting systems are described in, for example, co-pending commonlyowned provisional patent applications: “SUPPORT FRAME AND RELATEDUNWEIGHTING SYSTEM,” filed Mar. 14, 2013, application No. 61/784,387,attorney no. 10189-708.100; “CURVED ARCH UNWEIGHTING SYSTEMS,”application No. 61/772,964, filed Mar. 5, 2013, attorney no.11889-709.100; “UNWEIGHTING ARCH SYSTEMS,” application No. 61/773,019,filed Mar. 5, 2013, attorney no. 11889-710.100; “MONOCOLUMN UNWEIGHTINGSYSTEMS,” application No. 61/773,037, filed Mar. 5, 2013, attorney no.11889-711.100; and “CANTILEVERED UNWEIGHTING SYSTEMS,” filed Mar. 14,2013, application No. 61/784,510, attorney no. 11889-713.100, each ofwhich are incorporated by reference its entirety.

In a further exemplary implementation of the above described systems,there may also be available to a user a progression of personalassistance, unweighted training and rehabilitative systems along withother non-assistive or conventional exercise systems. This variety oftraining systems may be considered a continuum of care. An individualmay be training to recover from a stroke or surgery. Such an individualmay not be able to move without assistance. As such, one of theassistive devices described herein would be used as the starting pointfor this person's training or rehabilitation program. In one aspect, theuser may be provided with an assistive device that in this contextrefers to a device that may include an actuator or other form ofimparting locomotion to the user's limb or frame to assist the user inthe biomechanics of walking. In one aspect, there may be one or moreactuators coupled to the person's limbs or about one or more joints toaid in moving the person's limbs to provide assisted mobility training.Next, after some sessions and improvements, the person may progress toone of the various unweighting systems or other assistive trainingsystems described herein. After a progression through the stages ofassistive training, the person may progress to the use of unassistedtraining or exercise equipment. In general this continuum of care fromfully assisted (alone or in combination with unweighting training)progresses to unweighting types of training. The user may then progressto lesser amounts of unweighting (i.e., the unweighting system providesless and less assistance) as the user gets stronger and more able toaccomplish gait and mobility independently. Until the user reaches theuse unassisted exercise and independence of gait and other biomechanicaltraining and rehabilitation.

The systems described herein may also be configured to accommodate auser's progress through the above mentioned stages or continuum of carefrom assistive locomotion devices or systems, to unweighting systems tolesser degrees of unweighting systems to the use of conventionalexercise equipment and training systems. In the exemplary descriptionsof the implementation of these integrated training systems, the term“training device” is intended to include any of the herein describedtraining systems including assisted locomotion devices or systems oractuator based limb mounted components; non-DAP unweighting systems; DAPunweighting systems or conventional training systems such as treadmills,stationary bikes, elliptical trainers, stair climbers and the like.

Referring again to FIG. 5, the system downloads a treatment or workoutprogram to the appropriate assisted, unweighting or other trainingdevice. Either the training system or the treatment management andscheduling system may send an approval request to a medical professionalor to an insurance provider for approval. For example, a networkedtraining device could be pre-set for a workout session based onknowledge of who will be using the machine during that session. Aphysical therapist could adjust the program locally as required, eitherprior to or during the session. The system will allow for review andmodification of a recommended user program by the associated physicaltherapist or trainer. For example, in some embodiments, the systemallows a therapist to create or modify pre-programmed workout sessionsand attach these to an appointment scheduled by the user, overriding anysystem-generated workout session. In some embodiments, the trainingdevice or systems have editing capabilities on a display/control unitassociated with the treadmill, or on a mobile device by means of an“app.” In some cases the display or control unit is removable.

Once the treatment is set, the user gets into the training device orsystem and performs a treatment or workout according to the suggestedtreatment protocol provided either by the training device or system, thetreatment management and scheduling system, the physical therapist, or acombination of these.

In some embodiments, prior to starting the treatment, the user isidentified by the DAP system as the proper user for the specifictreatment. For example, the training device or system may be capable ofidentifying the individual user, based on some unique ID which ispresented to the machine prior to use. The system will know the age,sex, and medical diagnoses (if applicable) of each user. In someembodiments, the system may require that a user who has scheduled timeon a machine to identify themselves to the machine (via keypad, RFID,bar/QR code, magnetic card swipe, biometrics, or other identificationtechnology) at the beginning of their scheduled session. This providesconfirmation that the user kept the scheduled appointment, ensures thatany treatment protocol sent to the machine is used by the intended user,and allows performance data to be attached to that user's treatmenthistory. Where a patient does not have an identification means, the usercan create a profile. The training device or system may maintain aprofile of each user. In general, users will identify themselves priorto using the system. In some embodiments, a “guest” identification actsas a catch-all for users without a profile. The system will trackutilization by individual users and can report on utilization statisticsand workout parameters to the healthcare practitioner for medicalevaluation, to the user for personal medical and health records andmonitoring, and to third parties such as insurance providers orreimbursement agencies for medical reimbursement to the clinic orhealthcare practitioner or for compliance verification of activities bythe patient associated with medical insurance or wellness programmonitoring.

Advantageously, in some embodiments, a patient identification means canhelp monitor (and encourage) a patient's compliance with a treatmentprogram. The patient's identification means such as an access card maybe read by a medical professional during scheduled checkups to monitorthe patient's progress. Monitoring progress may also be used to track,monitor, adjust or improve upon a user's progression along the continuumof care as described above.

Once the user has completed his session, the user can provide feedbackto the training device or system in any number of ways. For example, thetraining device or system can receive and store information on theuser's satisfaction with the treatment, overall mood, level of pain,etc. In some embodiments, the training device or system is capable ofrecording a broad range of information about user performance, includingbut not limited to duration, speed, incline, percentage body weight,heart rate, and gait factors. Moreover, the training device or systemcan receive and store information provided by a medical professionalobserving the user's treatment on the training device or system. Forexample, a physical therapist may rate the user's progress and/orprovide notes on the user's treatment, or progression from one assistivedevice or technique to the next along the continuum of care describedabove. Any of this information can be directly entered into the deviceor training system either by a computer terminal interface connected tothe device or system or through a receiving means directly connected tothe device or training system. For example a touch pad monitor may beconnected to the device or system to receive input.

The device or training system may also be configured to send informationto another device such as a printer or computer. The information can besent via email to a doctor, insurance company, or a patient file. Inother embodiments, the information can be printed and added to aphysical file at the facility. Additionally, the information may be sentto the treatment management and scheduling system to be stored in thedatabase for archival and retrieval purposes. For example, the trainingdevice or system may be capable of transmitting that information to acentral information processing system.

In some embodiments, information is sent to a doctor or insurancecompany if the treatment protocol indicates that more sessions arerequired and the user does not have a prescription or insurance coveragefor the remaining suggested sessions. In some embodiments, a predictivealgorithm is used to evaluate whether a suggested treatment protocolgenerated by the training device or system or the treatment managementand scheduling system is consistent with the prescribed treatment by amedical professional. In one aspect, the system will also predict orrecommend the progression of a user from one type of assisted trainingdevice or system to another based on user performance, goals, historicaldata or one or more factors provided by a predictive training algorithm.If, for example, the predictive algorithm shows that the number ofcovered sessions remaining is less than the number of treatmentspredicted to achieve the desired outcome, the system (DAP, non-DAP,training device or system or treatment management and scheduling) willgenerate a reminder to the facility/therapist that re-authorization isrequired. The system may also generate the required documentation neededfor re-authorization.

In some embodiments, to determine proper scheduling of the appropriatetraining device or system, the treatment management and schedulingsystem evaluates criteria besides the machine being used, such asspecific therapist or skill set, whether the patient needs assistance inentering or using the machine (including need for lift access or aparticular personal training device or locomotion system or gaitmonitoring system), video recording systems, gait analysis capabilities,insurance qualification and provider network, and transportation to/fromthe appointment.

In some embodiments, the system will use data from gait analysis, userperformance, user experience, etc. to drive scheduling. For example, thetreatment management and scheduling system may receive and gather auser's information after the first treatment. Based on that information,the treatment management and scheduling system can provide the user withadditional sessions or a series of sessions for continued treatmentbased on the first treatment and the end goal. In other embodiments, thetreatment management and scheduling system continuously assesses theuser's performance and information after each session to determinewhether to modify treatment parameters or scheduling. For example, auser reports that they experienced pain during the appointment, thesystem may suggest delaying the next appointment, to allow for morerecovery time or may recommend a greater degree of unweighting, ordifferent unweighting system or technique at the next session. If themachine senses gait asymmetry that may be associated with musclestrength, the system may recommend possible strength or flexibilityrehab therapies as part of the PT evaluation and possible treatmentconsiderations and the system could monitor compliance with specificrecommended activities if such activities are performed on machinesconnected to the system or if the patient is wearing sensors that enabledata capture of such activity when not on connected machines.

In further embodiments, the treatment management and scheduling systemsallow a sequence of appointments to be scheduled, based on either anumber (e.g. 10 appointments) or a desired outcome (e.g. walking at 3%incline at 2 mph at 95% of body weight). Rather than schedule a singleappointment as described, multiple appointments can be scheduled by theuser according to desired number of appointments or treatment protocol.The system can monitor patient compliance with the treatment scheduleand can monitor patient progress toward the desired outcomes. Ifnecessary, the system can communicate recommended or possiblemodification to the treatment sessions required. Such communicationscould be provided to the healthcare practitioner, to the patient, to theinsurance provider or to other parties with associated data andrationale based on patient-specific or population data metrics.

In some embodiments, the treatment management and scheduling systemswill create a recommended program for a user's next appointment, basedon, among other things, the patient's purpose in using the machine,their current medical condition, their historical performance, andaggregate data collected by the system about the performance andprogress of other users with similar characteristics. The system may doso by comparing the user's performance data from the last treatmentsession with aggregated data collected by the system for a population ofusers. The system may then generate a recommended treatment program forthe user's next appointment based on the comparison of the user'sinformation and stats with the data for the population of users.

In some embodiments, the aggregated data may include a performancedatabase based on the demographic and medical data about users and theirrelated workout sessions. This performance database will include andaccumulate a qualitative measure from the user about their experience(e.g. pain, satisfaction) during the session. In further embodiments,the aggregated data may include and accumulate data from medicalpersonnel (e.g. physical therapists supervising users) as to the outcomeof a user's treatment session. This data will also be stored in theperformance database.

In some embodiments, the user may not have any prior experience with theassistive devices or training systems (either DAP or non-DAPunweighting). In such cases, the systems described can design a suitabletreatment based on the user's information. For example, a user with noprior DAP system experience may wish to use DAP to improve the user'srunning speed. To design the appropriate DAP system, the treatmentmanagement and scheduling system may receive the user's informationregarding the desired treatment result. In this example, the user mayinput into the treatment and scheduling system that she wants todecrease the time needed for her to run a mile. The user may optionallyinput additional information regarding her location and the time slotfor the treatment. The treatment and scheduling system then employs apredictive algorithm, such as the ones described above, to determine theappropriate treatment and DAP system for the user. The predictivealgorithm may compare the user's information to that in a database withaggregate data (including performance data) regarding the population ofusers that have used a DAP system. The algorithm then assesses thetreatment parameters employed by other users to determine what treatmentwould be suitable for the user. The treatment management and schedulingsystem may then provide one or more suggested treatments to the user andhave the user decide on a treatment.

In the case where multiple treatment options are available, the user mayfirst decide on the type of treatment. Once that is selected, thetreatment management and scheduling system may then determine whichtraining system, progression of systems or other rehabilitationequipment can provide that treatment regime. For example, if thealgorithm determines that users can improve running speed by modifyinggait or by running under positive pressure, the system may offer thosetwo treatment options to the user. If strength or flexibilityimprovement is needed along with use of the DAP system, for example,then scheduling system can recommend treatments involving multiple modesof therapy. If the user picks gait modification as a treatment, thetreatment management and scheduling system may then match the user withDAP systems having gait analysis capability. Alternatively, thetreatment management and scheduling system may offer the non-DAPunweighting systems to the user and indicate in the listing that thenon-DAP system selected can provide gait or an alternative unweightedtreatment.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modifications,combinations and variations could be made thereto by those skilled inthe art without departing from the scope of the various inventiveembodiments and alternatives described herein.

What is claimed is:
 1. An integrated unweighted gait training system,comprising: an unweighting system comprising a computer controller; agait measurement system in communication with the controller; and adisplay in communication with the computer controller adapted andconfigured to provide real-time feedback to a user of the integratedunweighting gait training system.